Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.

Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

By the time she was 61, Martha Rhodes had spent decades battling intractable depression. Diagnosis: treatment-resistant major depressive disorder. She’d tried a variety of medications to no avail; most were ineffective or caused nausea, diarrhea, weight gain and mood swings. During one particularly low evening in 2009, she attempted suicide. And every morning when she awoke, she experienced what she describes as “an emotional nausea – it was like this feeling of, ‘Why am I still here? Why do I have to be alive?’”

But four years ago, Rhodes, now 65, of Danbury, Connecticut, underwent a procedure she says saved her life: repetitive transcranial magnetic stimulation, which uses magnetic pulses to electrically stimulate nerve cells in the brain and is used by doctors to relieve symptoms of depression.

“My feelings of hopelessness, wishing I were dead and that life wasn’t worth living – all of that went away,” recalls Rhodes, who chronicled her experience with TMS in her 2013 book “3,000 Pulses Later.” Rhodes says she shares her story with others to demystify the treatment – which is often misunderstood by both patients and doctors, though it's increasingly used by medical practitioners nationwide.

What Is TMS?

TMS was first developed in the early 1980s, but it was only approved by the Food and Drug Administration in 2008 for patients like Rhodes, who’ve unsuccessfully tried one or more medications for their treatment-resistant depression and want to explore other options. That's according to Mark George, a professor at the Medical University of South Carolina in Charleston.

Depression, George says, is a disease that stems from a lack of activity in certain parts of the brain – specifically the prefrontal cortex, the region right above the eyes that helps regulate emotions. TMS is a technology that allows doctors to noninvasively stimulate that part of the brain and “exercise it back into health.”

During TMS, George says, a doctor takes a hand-held electromagnetic coil and holds it up to the front left side of the patient’s skull for nearly 40 minutes. The electricity creates a powerful magnetic field, which passes into the brain and causes neurons to fire electrical impulses. In turn, the electrical impulses encourage a chemical reaction that, over time, helps lift mood.

TMS is different from other brain-stimulation therapies, like electroconvulsive therapy. During ECT, patients receive anesthesia and are stimulated across the scalp with a very small electrical current. The current induces a short brain seizure, which produces changes in the brain’s functioning and chemistry. TMS, on the other hand, is a nonconvulsive procedure; patients don’t have a seizure, and they are awake and alert the entire time. There are also no cognitive side effects or memory loss in TMS, which physicians say are common – although benign – in patients who undergo ECT.

“But in some ways, the two procedures are similar,” George says. “We're trying to reset and wake up connections in the brain that aren't really working well.”

What Is It Like?

Five days a week, Rhodes, a former advertising executive, traveled to Hartford Hospital’s Institute of Living in Hartford, Connecticut, where she sat in a comfortable reclining chair with a magnetic coil affixed to the side of her head delivering 3,000 pulses to her prefrontal cortex. She was able to watch TV, read, receive visitors and relax. After the day’s procedure was finished, she drove herself home. This lasted six weeks, with a total of 30 sessions – a standard duration, doctors say, for a course of TMS. (Some patients decide to get TMS for shorter or longer periods – say, four or seven weeks – depending on their needs.)

Rhodes compared the sensation of having electrical pulses delivered to the side of her head in the form of four, 10-pulse bursts in a row (with a rest period of 26 seconds between each interval) to a woodpecker pecking her skull. She also had to wear earplugs to drown out the noise of the machine, which makes a loud tapping sound.

The treatment was “jarring” at first, but eventually Rhodes got used to it. Then about four weeks in, after her 19th or 20th daily session, she “felt this lightness,” she remembers. “All of the sudden, this cloud was gone.” Her depression had finally lifted – and right on schedule, according to doctors, who say that patients often experience relief from TMS within two to four weeks.

What Are the Side Effects?

There’s a very low risk of patients experiencing a seizure in TMS, says Irving Reti, an associate professor of psychiatry at Johns Hopkins University School of Medicine and director of the Brain Stimulation Program at Johns Hopkins Hospital. Side effects typically include a minor headache and localized pain underneath the magnetic coil.

Another possible side effect, says Lindsey Carpenter, chief of the Mood Disorders Program and the Neuromodulation Clinic at Butler Hospital in Providence, Rhode Island, is a twitching or vibrating sensation around the face, cheek or scalp.

Rhodes says she didn’t experience any of the above symptoms, although she did occasionally take Tylenol to ward off potential pain.

Who Gets TMS?

Research suggests ECT is a more effective treatment than TMS for relieving severe depression. Therefore, many patients choose ECT over TMS if they’ve tried multiple medications or therapies to no avail, or if they’re suicidal, psychotic or catatonic.

However, George says, some patients with treatment-resistant depression are reluctant to receive ECT – typically administered three times a week until a patient's depression is relieved, which can take anywhere from six to 12 sessions. They worry about memory loss, or they don’t want to invest the time. (Since ECT requires anesthesia, patients are generally out of commission on treatment days, and must rely on rides to and from appointments.) TMS, George points out, is also time-consuming, but it can be integrated into a daily routine. A person with depression that’s bad but not life-threatening might be a good candidate for TMS if they’ve already explored pharmaceutical options. If TMS doesn’t work, they might opt for ECT later down the line – a decision Rhodes says she might've made had the former treatment not worked for her.

Additionally, Carpenter points out, many psychiatric patients have multiple conditions or disorders, and therefore aren't good candidates for anesthesia. “We use TMS for a lot of patients that otherwise would’ve gone straight to ECT if they were healthier,” she says.

On the other side, there are people who aren’t eligible to receive TMS, Reti says. Those with a history of seizures shouldn’t have it, as well as individuals who have metal in and around their head – say, a metal plate. (Braces and fillings are OK.)

Does TMS Work for Everyone?

Unlike Rhodes, not everyone in the medical community is convinced of TMS’s effectiveness. The National Institute of Mental Health calls the results of past clinical studies “mixed,” and the American Psychiatric Association says TMS offers patients “relatively small to moderate benefits.” Until recently, many insurance companies wouldn’t cover TMS. However, newer studies are showing promising remission and response rates among patients, as well as prolonged periods of improvement post-procedure.

George estimates that TMS can help up to one-third of patients achieve remission. And about 50 to 60 percent of patients show some response, he adds, meaning their depression symptoms have lessened. “It’s a pretty effective treatment,” he says.

But physicians warn that not all patients respond to TMS – nor can anyone predict who will respond. And although many insurance companies now cover TMS, some still don’t, and others require prior authorization. Medical assistance programs like Medicaid don't always pay for TMS. And out-of-pocket expenses for six weeks of TMS can total up to $10,000 – a lot for a procedure that might not work. “Unfortunately, that's the case with all our treatments in psychiatry,” Carpenter says. “It's one of the most pressing research questions: Who's going to benefit from a certain type of treatment so you can spare people the time, money and energy?”

Such was the question for Christy Moceri, a 31-year-old grant writer from Gainesville, Florida, who underwent TMS in July 2011. Like Rhodes, Moceri was a prime candidate for TMS – she’d experienced depression for years and encountered numerous side effects with medications.

“There isn’t a ton of research on TMS, but what my husband and I found was promising, and we could see that insurance companies were becoming more likely to cover it,” Moceri says. “We knew about the firmly established effectiveness of treatments like ECT and this seemed to be based on a similar theory. So we decided to take a gamble.”

Initially, Moceri says, TMS made her feel better almost immediately. “Significantly, markedly better, with no side effects,” she says. “Everyone on staff [at the clinic] was very encouraged by my progress.”

But her success didn’t last: Moceri once again slipped into depression and didn’t want to pay for follow-up treatments.

Additionally, doctors note, TMS patients often need a “top off” of sorts – brief booster treatments in case depressive symptoms return. Fortunately, Carpenter says, most TMS patients respond well to these maintenance TMS sessions. “If it got you better once, it’s extremely likely to get you better again,” she says, and much more quickly than the first go-around. Nevertheless, researchers still don’t know how to predict how long the benefits of TMS will last until a patient gets sick again.

Rhodes doesn’t take antidepressants anymore, but she receives maintenance TMS once a month. Although it helps manage her depression, she says, serious depressive illnesses like hers are lifelong and recurring. “TMS is a tool, not a cure,” she says. The year following her first TMS treatment, Rhodes had several “tune up” treatments. She later experienced a depressive relapse and countered it with another 10 TMS sessions. If she goes too long without receiving it, she says, she experiences obsessive thought patterns, weepiness and agitation.

Overall, Rhodes says her life has been restored – even if her depression never quite leaves her side. “What I have achieved with this therapy,” she says, “is a sense of vitality – a sense of wanting to be alive.”

Abstract

Vagal nerve stimulators (VNS) are surgically implantable medical devices which are approved by the food and drug administration (FDA) for treatment of medically refractory epilepsy in children. Two children with seizures disorders presented to the pediatric otolaryngology clinic with complaints of stridor and sleep apnea following implantation of VNS devices. Both children were evaluated with flexible laryngoscopy, direct laryngoscopy and bronchoscopy. The children were noted to have contraction of their vocal folds and supraglottis and the settings of their VNS were adjusted until no further contractions were noted. Each child had resolution of their symptoms following adjustment.

"Mental illness impacts millions of Americans, and is a serious medical issue that demands the attention of the entire country. Throughout the care of these individuals, our behavioral health professionals explored and provided the patients and families numerous care options that went beyond their covered benefits. In our experience, successful outcomes require a partnership between patients, families, medical professionals and health plans. As a company, we are dedicated to working together to help those whose lives are affected."

The following is a script from "Denied" which aired on Dec. 14, 2014. Scott Pelley is the correspondent. Michael Rey and Oriana Zill-de Granados, producers.

Two years ago tonight, we were reeling from the shock of the murders of 20 first graders and six educators at Sandy Hook Elementary School. Since then, we've learned that the killer suffered profound mental illness. His parents sought treatment but, at least once, their health insurance provider denied payment.

Because of recurring tragedies and an epidemic of suicides, we've been investigating the battles that parents fight for psychiatric care. We found that the vast majority of claims are routine but the insurance industry aggressively reviews the cost of chronic cases. Long-term care is often denied by insurance company doctors who never see the patient. As a result, some seriously ill patients are discharged from hospitals over the objections of psychiatrists who warn that someone may die.

Katherine West

In the pictures, there's no sign of the torment of Katherine West. But by the age of 14 she was wasting away, purging her food. Nancy West, Katherine's mother, was told by her doctors that the bulimia was rooted in major depression.

Nancy West: In fact, prior to the eating disorder, she was cutting so there were self-harming behaviors from, I would probably say, at least 12 on.

To stop purging she had to be watched around the clock. Her doctors prescribed treatment that could cost more than $50,000 at a hospital, for 12 weeks.

Scott Pelley: The insurance company stopped paying after six weeks?

Nancy West: Six weeks pretty much was it for them. They were done. And if you know about a mental illness, you don't cure a mental illness in six weeks.

The health insurance company was Anthem, second largest in the nation. An Anthem reviewer found Katherine should leave the hospital because she had put on enough weight. Her doctor warned that she was desperate to shed those pounds.

Nancy West

CBS News

Nancy West: They were telling the insurance company, "She needs to stay here. She needs more long-term treatment. She isn't ready for this."

The insurance company overruled the doctor. Katherine West came home as an outpatient.

Nancy West: I was texting her, no response. I got home at 12:30 that day and I found my daughter in bed. She'd been gone for hours. And I just remember running through the house screaming. I couldn't believe it. My beautiful girl was gone. She was gone.

Katherine was dead at the age of 15. As her doctors predicted, she'd been purging again, which led to heart failure.

Scott Pelley: Did it make sense to you that a doctor at the insurance company was making these decisions based on telephone conversations?

Nancy West: No. No, they didn't observe my daughter. You're talking about a psychiatrist, a pediatrician, a therapist who observed my daughter on a daily basis. But some nameless, faceless doctor is making this decision. And I was furious. Because basically to me he was playing God with my daughter's life.

The kind of review that resulted in the discharge of Katherine West works like this; after a patient is admitted, an insurance company representative starts calling the doctor every day, or every few days. If that representative decides that the patient is ready for a lower level of care, then the case is referred to an insurance company physician who reads the file, calls the doctor and renders a judgment. We have found in these chronic, expensive cases that judgment is most often a denial. How often the results are tragic, no one can say. But we have found examples.

"...some nameless, faceless doctor is making this decision. And I was furious. Because basically to me he was playing God with my daughter's life."

In 2012, Jacob Moreno's further hospitalization was denied even after a doctor warned, "the patient states that he wanted to kill other people, many people." The next day, Moreno was naked in the street, swinging at strangers and attacking a police officer. They used a Taser to take him down. The state ordered him back to the mental hospital. Richard Traiman's hospital stay was also cut short. As he was being discharged, he said he would throw himself off a bridge. He didn't. He hung himself the next day.

Dr. Harold Koplewicz knows insurance review calls well, he's a leading psychiatrist and founder of a research organization, the Child Mind Institute.

Harold Koplewicz: When I was running an inpatient unit, I would have to literally speak to a clerk on the phone to say, "I need approval for this patient to stay here another five days." And they would say to me, "Well, is the patient acutely suicidal or acutely homicidal?" "Well, not right now because he's in the hospital. We took the knife away. We took the gun away. We took the poison away." And they would say, "Well, then why does he have to be in the hospital?" You think to yourself, "Am I in--is this Oz?"

Scott Pelley: The insurance company wants to send 'em home?

Harold Koplewicz: Well, it's a lot cheaper in the short run. And if you're managing costs on a quarterly basis, you can understand why from a business point of view for that quarter it makes sense. For the sake of the child, for the sake of our society, for the sake of the child's future it doesn't make any sense

Of all the cases we looked at, one of the most revealing was Ashley's. She suffers from bipolar disorder.

Ashley: In 2012, I had had a suicide attempt. I couldn't find a way out.

Scott Pelley: Was this a cry for help or did you want to die?

Ashley: This one was real. I was alone. I tried my best.

Ashley's mother, Maria, asked us not to mention the family name.

Maria: One of the doctors told me on the phone, "I'm really sorry, but you will probably bury your daughter."

In 2012, Ashley was in the hospital for the fourth time that year. They thought they had taken away everything that could hurt her. But she smashed her cell phone and cut her wrists with the glass.

Scott Pelley: What did that tell you, in terms of the treatment that she needed?

Maria: It told me that she needed long-term treatment to survive.

Maria says that Anthem recommended treatment at Timberline Knolls, a residential facility. A doctor said Ashley needed 90 days. But after sending her to Illinois from California, Anthem denied payment after six days saying that Ashley could be, "safely treated with outpatient services."

Scott Pelley: Did the people at Timberline Knolls believe that?

Maria: No, they didn't--

Scott Pelley: That she was well?

Maria: No. They absolutely didn't believe it. They gave us the option of paying $22,000. For-- to complete the 30 days. And at that, we-- there wasn't a chance that we could do that.

Now, look at how Ashley's care was denied. This log shows Dr. Tim Jack, a psychiatrist working on behalf of Anthem, called Ashley's doctor three times in 32 minutes. One call was disconnected. He left two messages. Dr. Jack waited 22 minutes for a call back, and then denied coverage. From the first call to denial, 54 minutes, speaking to no one.

Why so fast? Well, it may be, in part, because many insurance doctors are paid by the case. Dr. Jack, is a contractor who gets $45 per patient. In court records, Dr. Jack says he does 550 reviews a month. So, working from home, that comes to $25,000 a month. We spoke to 26 psychiatrists from across the country, and every one brought up Dr. Jack's name. Some called him "Dr. Denial." This is a recording of Dr. Jack telling a physician that a patient's level of care should be lowered.

Dr. Tim Jack: Because given what his current progress is and his current symptoms are, he can be managed at a lower level of care as effectively as in an intensive outpatient program.

Doctor: You know doctor, I just want to say that I have spoken to you on so many different occasions, and with so many different clients, and I've never really had a positive outcome as far as authorization from you, so...I just needed to bring that to your attention.

Dr. Tim Jack: This is not a personal matter.

Doctor: I understand sir, but the client appears to meet the criteria, so...

We found Dr. Jack's denial rate averaged 92 percent in one six month period in 2011. But that was typical among 11 reviewers contracted by Anthem. Some of them had denial rates of 95 and 100 percent.

Scott Pelley: What's the impact on a family after a phone call like that?

Kathryn Trepinski: Devastating.

Kathryn Trepinski is a lawyer who represents patients. She does not represent Ashley's family, but she has filed suit against Anthem and other insurers.

Kathryn Trepinski: There's untold suffering and the family is usually left in the very difficult-- position of either paying for the care out of pocket, which is tens of thousands of dollars. Or they say no to their loved one, to their child.

Anthem says that reviews are checked by a supervising doctor but when we obtained Ashley's denial letter we found her review by Tim Jack, MD, was supervised by Timothy Jack, MD.

Dr. Jack has acknowledged an Anthem computer put his name to letters he doesn't see and on cases he didn't review.

Kathryn Trepinski: It suggests a layer of review that's not there. Because the signing doctor is described in the letter as having made that coverage determination and he didn't.

We tried to reach Dr. Jack in calls and a letter. We stopped by his home. But he declined to speak. Katherine West's and Ashley's parents gave us permission to ask Anthem about their cases. Anthem declined an interview but its chief medical officer wrote that they, "explored and provided the...families numerous care options that went beyond their covered benefits." He goes on to say "successful outcomes require a partnership between [sic] patients, families, medical professionals and health plans."

For the insurance industry's view, we found Anthem's former California medical director, Dr. Paul Keith. He retired in March after years supervising Anthem reviews, including those of Dr. Jack. He told us that, too often insurance companies are abused by care providers.

Dr. Paul Keith

CBS News

Dr. Paul Keith: Doctors will spin the clinical information. They will make things appear more serious than, perhaps, they are, because they feel strongly the patient needs this level of care for a little longer. So you do have a somewhat adversarial relationship between the reviewer and the attending physician.

Scott Pelley: You're saying the-- the doctor will overstate the case to get the insurance company to approve the client?

Dr. Paul Keith: Unquestionably that happens. Not all the time and I've been doing this for, you know, over 30 years.

Scott Pelley: You describe these conversations as "adversarial," is that best for the patient?

Dr. Paul Keith: Well, it's like our legal system if you, each side, does a good job in presenting their case and asking the right questions, you ultimately arrive at the truth.

Scott Pelley: But these can be life and death decisions and you don't know till it's too late.

"Doctors will spin the clinical information. They will make things appear more serious than, perhaps, they are, because they feel strongly the patient needs this level of care for a little longer..."

Dr. Paul Keith: I cannot, offhand, think of a situation where a decision was made to discharge a patient from a hospital and some terrible consequence occurred soon thereafter. I'm sure it happens, but--

Scott Pelley: We found quite a few.

Dr. Paul Keith: I'd have to look at them to see. There's one that occurs to me that I was involved with where the child left the hospital with his parents, escaped from his parents, drove cross country to another state, and days later, committed suicide. Keeping that individual in the hospital longer is not likely to have made any difference.

Scott Pelley: I would have to imagine that the parents would say, "If you'd kept him in the hospital, he wouldn't have been in another state killing himself."

Dr. Paul Keith: Parents become fearful that if they leave too soon, the same thing's gonna happen that may have happened in previous occasions, but you can't keep an individual in the hospital forever.

Scott Pelley: So to the parent who says the insurance company is just trying to get my child out of the hospital, you say what?

Dr. Paul Keith: It's half true; the insurance company may very well want that child to go to a lesser level of care, but money is not the basis for the decision.

Scott Pelley: A lot of people watching this interview are gonna have trouble with the idea that insurance companies are not trying to save money.

Dr. Paul Keith: Of course, your insurance companies are trying to save money. There's a lot of treatment that is not medically necessary that is provided, and that is a waste of healthcare dollars and the resources are scarce.

Ashley's family hired a lawyer and appealed to the California Insurance Board which overturned Anthem's denials. Now, she is in treatment for bipolar disorder, treatment that may last a lifetime. Katherine West was buried a year ago this month, her mother has filed suit against Anthem.

After the mass murder at Newtown, the state of Connecticut's Sandy Hook Commission studied mental health. A draft of its upcoming report calls the insurance review process a "formidable barrier... to care" and recommends a state agency review all denials.

Nice media presentation on your part except for the fact it doesn’t even scratch the surface of the inequities, discrimination and subterfuge perpetrated against those with mental health issues.

I have been battling with HHS and CMS as well as Madam Secretary Sylvia Mathews Burwell as well as Stephen J. Hemsley - CEO, United Healthcare to rightfully cover patients who have benefitted from VNS Therapy for Depression.

How’s about this fact?I finally cajoled CMS to cover the Medicare/Medicaid study subjects and patients for their medical insurance.Here’s the sad joke.United Healthcare as a result of CMS’s prompting has covered Medicare patients but refused to cover private pay patients.Same company, same therapy but Stephen J. Hemsley - CEO, United Healthcare, who’ve I written to many times, refuses to cover at least one of his private pay patients.

Volunteer study subjects with implanted medical devices left to their own challenges to obtain medical coverage and care.Screwed up and discriminatory mental health care system; you bet.

My efforts to overcome this abortion can be found in my writings on blog site:

Wednesday, December 10, 2014

Patients that suffer from severe depression and would not respond to normal therapies have been found responding to nitrous oxide or laughing gas treatment.

A research conducted at the Washington University School of Medicine in St. Louis has shown patients with treatment-resistant clinical depression improved significantly within a day or two of being administered with nitrous oxide.

Nitrous oxide, also known as laughing gas, is an inhalation anesthetic used in dentistry and surgery – but has been found helpful for treating depression. Twenty patients were administered with this gas, and two-thirds reported significant improvements 24-hours after receiving laughing gas, while a one-third that received placebo reported they were not in any way better.

In order to be certain of the results achieved with nitrous oxide, the researchers replicated their trials and the same findings were obtained. Patients with severe depression were given two kinds of treatments – but neither the patients nor the researchers understood the order for administering the treatments; a group of patients were given a mixture of half oxygen and half nitrous oxide, and the other group was given a placebo mixture of oxygen and nitrogen – the two atmospheric gases we breathe in the air.

The first group that got half oxygen-half nitrous oxide reported a day after the gas was administered that feelings of sadness, guilt, anxiety, suicidal thoughts, and insomnia was greatly diminished: seven patients reported significant improvements, seven confirmed they had mild improvements, three confirmed that their conditions were almost disappeared, but no patients reported any side-effects.

The second group that had placebo treatment reported very little improvements: one’s condition worsened after the treatment, two others experienced considerable improvement, and five reported they only felt better.

But according to Dr. Charles R. Conway, “most patients that received nitrous oxide reported rapid and significant improvements in their health conditions.”

Published in the journal Biological Psychiatry, the researchers are interested in knowing if laughing gas could be administered to other groups of patients with depression – and they intend to test out various concentrations of the gas to determine how it influences the treatment of depression symptoms.

Monday, December 8, 2014

Cyberonics Reports Consistently Positive Results From The E-36 And E-37 Studies For VNS Therapy Delivered By AspireSR® Generator New Results Presented at the 68th American Epilepsy Society (AES) Annual Meeting

HOUSTON, Dec. 8, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX), maker of the VNS Therapy® System implanted in more than 80,000 patients, announced new results from two multi-site clinical studies of the AspireSR generator, E-36 (NCT01325623) and E-37 (NCT01846741), at the AES Annual Meeting in Seattle, Washington. The AspireSR generator is currently investigational in the U.S. and not approved for commercial use. The AspireSR generator attained the CE Mark and is now available in an increasing number of European countries.

Investigators presented results from the European E-36 study and the U.S. E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life. Assessments of seizure severity and quality of life were made using validated scales scored by patients[1],[2] and physicians[3].

The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies. Seizure activity was recorded using concurrent video-EEG and ECG monitoring. Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.

During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery.

"These clinical results show that the AspireSR VNS Therapy System is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy," said Paul A.J.M. Boon, MD, PhD, Professor and Chairman of the Department of Neurology and Director, Institute for Neuroscience, Ghent University Hospital. "The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS Therapy systems, but with added convenience to both the patient and caregiver."

"More than 60% of patients receiving VNS Therapy report benefits from manual magnet activation[4], yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura," added Robert Fisher, MD, PhD, Director of the Stanford Epilepsy Center, Palo Alto, CA. "The AspireSR generator delivers programmed VNS Therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures. This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy."

About Drug-Resistant Epilepsy and VNS Therapy

Epilepsy is the fourth most common neurological disorder and one in 26 people will develop epilepsy at some point in their lifetime. Antiepileptic drugs are typically the first option for treating epilepsy. While many people with epilepsy have success with these drugs, as many as one-third of people with epilepsy experience seizures that persist in spite of treatment with medications alone.[5],[6]

Cyberonics' VNS Therapy System is an FDA-approved medical device specifically developed for the adjunctive treatment of drug-resistant (medically refractory) epilepsy. Treatment with VNS Therapy does not involve brain surgery, but rather the implanted medical device delivers mild, pulsed electrical signals to the vagus nerve, which projects to areas of the brain that are known to be implicated in seizures. Studies show that a majority of people with drug-resistant epilepsy experience a 50-90% reduction in seizures with VNS Therapy[7] and report improvements in quality of-life[8].

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning obtaining FDA approval for and expanding the commercial market for the AspireSR generator. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission ("SEC"). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 25, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.

I wish you and your family a very Happy and Peaceful Thanksgiving and as always thank you for the courtesy of your prompt replies.

For some time now I’ve sensed there is a major case happening within HHS/CMS regarding VNS Therapy for Depression. It wasn’t until just recently that I was able to pin down the case without being able to obtain additional pertinent information. What I found is the following:

I was wondering whether you could direct me to some Internet link and/or if you could explain as well as elaborate upon the aforementioned NCD Number and Board Docket Number as to the participants and the nature of this legal action. Normally in a legal action one is able to research the docket number and read the nature of the plaintiff’s complaint/action.

At the moment, I’m stymied.

As always, thank you for the important help you’ve lent to some of these seriously ill patients who are most importantly continuing to do well through you’re assistance in obtaining replacement devices.

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I received your voicemail this morning. I apologize for not being able to call. This is a short week and lots of activity is going on in the office. Everyone working to complete assignment and assist beneficiaries prior to the holiday. Unfortunately, I will not have the opportunity to return your call. However, I did want to reach out and ask you if you could send me your question via e-mail? This way, I can read, work and respond faster to your inquiry.

If I don’t hear from you prior to the holiday, have a great Thanksgiving. J

Last week, a patient contacted me to find a psychiatrist because his anxiety was beginning to get out of control. He wanted to see someone who could do therapy and prescribe medications if he needed them. I gave him some names but warned him that none of them took insurance. If he wanted to find a psychiatrist that took his insurance, he’d need to call his insurance company to find one.

And this situation is not uncommon in my primary care practice. I can treat simple psychiatric conditions like depression and anxiety but, like many internists, I do not have the training to provide therapy or treat more severe psychiatric conditions. If a patients needs psychiatric care, the best I can do is to offer them some recommendations and tell them to contact their insurance company. As you can imagine, this poses a barrier for patients trying to access the psychiatric care they need.

Half of psychiatrists do not take insurance

This motivated me to study psychiatrists and insurance. Last year, a team of researchers and I published a study using data from a national survey of doctors examining this issue.

We found that almost half of psychiatrists take don’t take health insurance – whether it’s private health insurance, Medicare (insurance for the elderly), or Medicaid (insurance for the poor).

Specifically, we found that in 2009 to 2010, only 55% of psychiatrists took private health insurance, 55% took Medicare and 43% took Medicaid. This presents a significant barrier for patients who need to see psychiatrists.

It’s important to emphasize that this was a sharp contrast to every other type of doctor. For example, 94% of cardiologists took private health insurance during that same time period and 95% of general internists took Medicare. When pooled together, 88% of physicians all specialties other than psychiatry took private health insurance and 86% took Medicare. Acceptance rates for Medicaid were low overall because reimbursement rates are low. Nevertheless, psychiatrists had some of the lowest Medicaid acceptance rates of all specialties.

The results shocked us and when our study was published last year, we learned that the results also shocked the general public.

Doctors, patients and reporters corroborated our findings. I started to hear more and more stories of patients who struggled to find a psychiatrist who took their insurance.

Less money for more work

So why is this the case? First, low reimbursement may be a problem. Medicare pays US$130 to US$140 for a new visit to a psychiatrist. Although that rate is not much different from a visit to a primary care doctor, visits to psychiatrists may be longer because they involve counseling and therapy.

Second, a shortage of psychiatrists may also be factor. From 2000 to 2008, 14% fewer medical students chose to pursue careers in psychiatry and 55% of psychiatrists are over 55 and close to retirement age. As a result, many psychiatrists may have so much demand for their services that they do not need to accept insurance.

Finally, psychiatrists may not have or need the administrative capacity that other doctors need. A psychiatrist may be able to function without a lot of staff like nurses, medical assistants, and administrative assistants. Because of this some psychiatrists may not be motivated to hire that staff just to interact with insurance companies.

Possible solutions

Since the time of our study, our team has been developing ways to further study the problem but also to explore solutions.

One obvious step is to increase reimbursement for mental health-care. But such changes can be difficult. Medicare relies on a review panel of physicians to change reimbursement and it is unclear whether that panel will suggest increased reimbursement for psychiatrists.

But there are other promising options that make it easier for patients to access mental health care. For example, the New York City Department of Health and Mental Hygiene runs a program called Lifenet which patients can call to find a psychiatrist or other mental health provider in New York City who takes their insurance.

Another very effective program, called Impact, was developed by faculty at the University of Washington and helps primary care physicians treat depression. A nurse, social worker or psychologist works closely with patients in the primary care doctor’s office and has a designated psychiatrist to help with patients who are not improving.

These are good starts but much more needs to be done in order to ensure access to psychiatrists across the board. For now, I have told my patient that he will probably have to pay for his psychiatric care even though he has insurance or will have to find someone who takes his insurance without my help.

This morning’s conference call on Cyberonics yielded some cursory and interesting tidbits relating to VNS Therapy for Depression. First item of interest was the fact an “estimated 35 implants” for depression in the past quarter. The figure presented did not breakout new or replacement implants:

Thank you, Dan. First, the U.S. epilepsy market. The second quarter showed some improvement from the first quarter of fiscal 2015. First the good news: we estimate that a record number of patients were implanted with VNS in the U.S. during this quarter, including new patients, replacements, and an estimated 35 depression patients. However, U.S. sales fell short of our expectations. Although the comparative quarter last year was very strong, we expect more robust growth in an underpenetrated epilepsy market.

In several of my previous collaborations there was a hint of something legal going on within CMS which was hush, hush? No one cared to elaborate. I’ve gleaned from today’s conference call the following information for whatever it is worth. My opinion on the subject based upon today’s market reaction and an approximate 13% upswing in price despite what I would opine as lack-luster performance for the quarter is that something big is going on and there may have been some leakage of information that I feel could potentially be favorable to the VNS Therapy Depression patients. Let’s put it like this; I certainly hope so.

Okay. Great. And then in terms of depression, and the tribunal for HHS, and the appeal process that's being done by the patient, do you have any update on this tribunal, or anything you can give us there?

Medicare and Medicaid were passed to serve as safety nets for the country’s most vulnerable populations, a point that has been reemphasized by the expansion of the populations they serve, especially with regards to Medicaid. Yet, even after 50 years, the disabled population continues to be one whose health care needs are not being met. This community is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that cover the population as a whole and their acute and long-term needs.

The Affordable Care Act (ACA) has taken steps that should help, such as expanding coverage, but disparities arise from health status and access to care as well. To illustrate, one study looked at disparities between the disabled and nondisabled within Medicare to minimize the effect of coverage. Nearly 50 percent of the disabled population reported putting off or not seeking care due to cost concerns, and they were more likely to have negative consequences as compared to nondisabled Medicare beneficiaries who delayed care due to costs. Furthermore, disabled beneficiaries were three times as likely to have difficulties finding a doctor who accepted Medicare than nondisabled, and for the lucky that did 15 percent had difficulties finding doctors who actually understood their disability or how to treat it — not to mention obstacles arising from inadequate equipment and facilities, and insufficient communication, which is critical to patients’ rights of informed consent and bodily integrity.

The ACA contains provisions aimed at tackling some of these barriers to care, including standards for accessible medical diagnostic equipment, and developing trainings to provide culturally competent care to the disabled. Proper training is critical as many of the health disparities that the disabled suffer are due to the fact that the health care system is not designed to care for this population effectively. The disabled suffer from others’ belief that they lack the ability to achieve high-functioning lifestyles, which is illustrated by the fact that health care staff rarely, if ever, emphasize health promotion.

This is not to insinuate that the issue of coverage, or coverage of the needs of the disabled, has been rectified. A combination of states’ right to implement eligibility criteria, Medicaid being a target for budget cuts, and the disabled costing more than any other group has left many in the disabled community without much needed coverage. The ACA originally expanded Medicaid to anyone at 133 percent of the federal poverty line (FPL), but the Supreme Court made this optional. With 23 states still not moving forward on expansion, there is a need for advocacy and persuasion to try to limit the force of partisan politics. While other safety net features are available, Medicaid can offer assistance to the disabled through long-term care as well as standard necessities. Medicare on the other hand requires nonelderly disabled individuals receive SSDI benefits for at least 24 months — they must be unable to engage in gainful activity for at least 12 months to qualify for SSDI — and long-term institutional or community-based services are uncovered.

This perverse incentive to avoid work, or punish those that do work, is an issue the disabled community faces all too often. Expanding employment options for the disabled is important not only monetarily, but also to enhance their ability to live independently and interact with their social environment. Too often they are cut off from large parts of society, which undoubtedly lead to their higher rates of depression and mental illnesses. The Community Living Assistance Services and Supports (CLASS) Act aimed to help alleviate some of the concerns over long-term care, but it was ultimately deemed unsustainable. Nevertheless, with the disabled population growing, leaving their long-term medical needs to linger until they become more costly is not an economically efficient solution.

The safety net that Medicare and Medicaid aimed to create 50 years ago is still filled with far too many gaps when it comes to the disabled. The ACA has taken some important steps, but more needs to be done to ensure the health care system, including Medicare and Medicaid, reduces its barriers to health. Coupling policy changes with better information and training should also contribute to a much needed normative change, so that we no longer perceive those with disabilities as having something wrong with them or being unable to function “normally.” It is essential that as a country we recognize that health disparities for the disabled are associated less with their disability and more with our inability to structure the societal and health care framework to allow them to function optimally.

Subject: It's not about patient care and wellness. It's not about experimental treatments. It's all about money and profits (Part 1)

Dear Madam Secretary Burwell,

Nope, you haven’t heard the last from me. I’ve just been busy caring for my spouse Joyce and taking a little break from my advocacy/activism to recharge my batteries. Although this past week or so has proven interesting as I’ve received two (2) emails one of which I am awaiting permission to share publicly.

One of those emails was from another VNS study subject who advised me that her health insurance company, BlueShield and BlueCross of South Carolina has denied her replacement surgery for her VNS prosthesis. Cyberonics who guaranteed replacement for all the study subjects, of which she is one, has also denied her replacement coverage. Despite the fact that she is doing well these past 14 or so years and game fully employed as a professional her health insurance company, both from a medical and financial standpoint, exhibit their stupidity in not understanding they’ve been saving money. That is until she lapses back into depression and the medical expenses begin to mount. And you Madam Secretary and your bureaucracy continue to sit there without understanding or aiding these patients. Nor does it seem you’ll understand that if and when she lapses back into depression and is unable to work she’ll eventually end up on Medicaid and/or social security disability while being treated with the same ineffective treatment regimens and medications that cost our country trillions of dollars when all that need be done is for her to continue her current VNS treatment regimen and wellness as well as a taxpaying citizen.

I truly hope you’re proud of the agencies you command and the injustices and medical and moral negligence and inhumanity your FDA and CMS agencies has perpetrated against innocent citizens. Your agencies have truly victimized these patients despite having health insurance and being denied medical coverage. Why have you not had CMS issue a formal document not only to your Medicare/Medicaid agencies but to the private health insurance carriers informing them that all patients implanted prior to National Coverage Analyses (NCA) of May 4, 2007 are to rightfully to be covered for their medical care? How can you allow patients to be implanted with medical devices and have their health insurance carriers deny coverage? How can the government standby and allow Cyberonics to issue a guarantee of medical care and allow them to renege on that very care? Oh I forgot, our wonderful governmental bureaucracy and “it’s not my job”. Maybe we should add several more agencies to our already bloated bureaucracy to correct the problem (joke; only it’s not funny). It seems no one in government knows how to do “the right thing” other than to create more agencies and do nothing bureaucracies where one hand doesn’t know what the other hand is doing (i.e. “9/11” and CIA, FBI and local police departments, Federal fraudulent tax returns and IRS, FBI and local police departments and Pain Clinic Fraud and Medicare/Medicaid and VNS Therapy and FDA, Cyberonics and CMS all lacking effective communication) but to name a few.

The other item of interest came in another email regarding the name of Dr. Amy Schneider. Her name first appeared to me as a medical authority who wrote a psychiatric medical opinion for United Healthcare as to why their private pay subscriber should not be allowed to have her VNS prosthesis replaced and paid for by her insurance. Then oddly enough I just learned that the same Dr. Amy Schneider issued her medical opinion to United Healthcare once again in a different case as a medical authority on oncology. It seems Dr. Schneider was denying a cancer patient the use of a less invasive and less damaging radiation treatment. It seems to me that United Healthcare exhibits a lack of medical ethics in what appears to me to be a hired gun (hack) to justify denial of coverage. I’d say to Stephen J. Hemsley - CEO, United Healthcare that you couldn’t care less and didn’t help your subscriber, the VNS patient that I wrote to you and advocated for, but in this case I think you and your company have got its nuts in a wringer and you’re going to be taken to task for your lack of humanity and ethics. Bless the Internet. These people came across my previous commentary to you about your Dr. Amy Schneider and it greatly raised their interest. To you Mr. Hemsley I say both you and your company have been, “Penny wise and pound foolish”.

All the hoopla has passed regarding the death of Robin Williams and his suicide. The media has finished their frenzy of 24/7 non-stop verbiage about the tragedy but the fact remains that those of us on the frontlines know the issues and the deaths will continue and the reason for our continuing advocacy and activism for newer treatments and the dissemination of needed information.

Dear Madam Secretary Burwell it’s truly disgusting for me to sit here and watch people suffer especially when you and others have the authority and ability to ease the pain, anguish and suffering by doing good and what is truly the right thing.

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

Tuesday, November 18, 2014

Magnetic therapy gains favor in battling depression

Neuropsychiatrist Dami Salami (left), medical director of the repetitive transcranial magnetic stimulation program at Froedtert & the Medical College of Wisconsin, says rTMS has been successful in treating depression. With Salami is Yagna Pathak, an rTMS technologist and researcher.

By John Keilman, Chicago Tribune

Nov. 18, 2014 10:07 a.m.

Chicago — A machine that sends magnetic pulses into a patient's brain has become the new frontier of depression treatment, promising to ease symptoms for those who have found little relief from medication or talk therapy.

The treatment, known as transcranial magnetic stimulation, or TMS, is part of a wave of technologies that attempt to jolt the brain back to health. It caught on quickly after the Food and Drug Administration approved its use six years ago.

A form of it called repetitive transcranial magnetic stimulation, or rTMS, is being used with success at Froedtert & the Medical College of Wisconsin, according to neuropsychiatrist Dami Salami, an assistant professor of psychiatry and behavioral medicine at the Medical College of Wisconsin. Salami is medical director of the Froedtert & Medical College rTMS program.

"It's very promising, and I suspect it's going to be a major tool going forward," he said, noting that there's "limited awareness of this new treatment option." It has been used at Froedtert & the Medical College since 2011.

Though some have questioned the technology's effectiveness, more insurance companies are starting to cover it, helping with a price tag that can reach $10,000 for six weeks of treatment. It's covered by Medicare, Salami noted.

"What this does is raises (your mood) up to normal," a 55-year-old woman from the western Chicago suburbs said after finishing a treatment session at Linden Oaks at Edward in Naperville, Ill. "You can operate."

Stimulative brain therapies have been around for decades, the best known being electroconvulsive therapy, a technique that uses an electric current to cause a seizure. It was portrayed as a mind-erasing menace in the movie "One Flew Over the Cuckoo's Nest," though psychiatrists say the procedure is safe today.

Other methods use implanted devices to send electrical pulses to the vagus nerve — a transmission line that carries messages to the brain's mood center — or to the brain itself. Some studies have found that these techniques help to elevate the moods of people with severe depression.

Mark George, a South Carolina psychiatrist who edits the medical journal Brain Stimulation, said TMS produces similar effects without the need for surgery.

A patient sits in a chair that resembles something from a dentist's office as a device containing the magnetic coil is placed on his head. When it's activated, George said, magnetic pulses penetrate the skull and stimulate nerve cells — the Linden Oaks patient described the sensation as "having a woodpecker sitting on your head" — provoking a therapeutic response.

George acknowledged that the technology doesn't work for everyone. Early studies, which relied on subjects who had been taken off their medications, found that only about 15% saw their depressive symptoms go away.

But later research that allowed subjects to stay on their meds, which George called a more true-to-life test, found that 40% had complete relief from their symptoms, while 60% got at least somewhat better.

Salami says the repetitive TMS he uses involves a brain MRI to identify a specific treatment site, is more targeted than traditional TMS and has been effective in 80% of cases. By contrast, he notes, the response rate for medication is 50% to 60%.

The treatment is especially helpful in what he called resistant cases of depression, defined as those who have not experienced remission of depressive symptoms after at least two treatment modalities — meaning medications and/or therapy.

"It uses magnetic field pulses over a specific period of time," he said of the method used at Froedtert & MCW. "The repetitive nature is key with treatment resistant cases. We can modify the way we deliver treatment, and the treatment parameters ... the strength of treatment parameters. ... We can increase the magnetic field current and frequency, and the band width."

It's not as effective as electroconvulsive therapy, which has full remission rates of around 60%, but George said that treatment requires patients to be anesthetized and is known to cause memory and cognitive problems in some.

TMS, by contrast, requires no sedation, and its biggest complication appears to be discomfort where the magnets are placed on the head.

Salami said rTMS doesn't carry with it the side effects of medications, and patients can return to work or other activities after a treatment session. The treatment has been used for patients with Parkinson's disease and for chronic pain at other centers, he said, and there are ongoing studies looking into its effectiveness in other disorders, including obsessive compulsive disorder.

"It's a highly effective treatment and has only trivial side effects," said physician Jesse Viner, medical director at north suburban Evanston's Yellowbrick psychiatric health care center. "There's no persistent adverse effect. You can have a little bit of a headache or facial pain, but that quickly subsides, and in our experience, by the time people have their third or fourth treatment, they're OK."

The effectiveness of TMS came into question in 2007 when the FDA was considering its use as a depression treatment. The Washington-based advocacy group Public Citizen, which often tangles with the agency over what it considers lax standards for medical devices, claimed the study the FDA relied on was unreliable.

The data at first showed that TMS was not significantly superior to a "sham treatment" that didn't subject patients to the magnetic pulses, the group said: Better results from TMS were evident only when some subjects were removed from the trial, and even then the difference was small.

What's more, the group said, patients receiving TMS knew they were getting something because unlike the sham treatment, the pulses produced a painful sensation.

"Given the small differences we were seeing, that could have been explained by the placebo effect," said physician Michael Carome, director of Public Citizen's health research group.

Physician David Brock of Neuronetics, the Pennsylvania-based company that sought FDA approval for its TMS machines, pointed to a rebuttal by the study's authors that defended their methodology and cited the improvement made by patients who received the treatment. Subsequent research, Brock said, has further demonstrated the effectiveness of the technology.

The FDA decided to allow TMS as a depression treatment, and many Medicare contractors have since covered the service. Though private insurance companies remain split, with companies such as Blue Cross and Blue Shield of Illinois paying for TMS and others declining to do so, more than 100 million people now have coverage for the treatment, Brock said

That has encouraged more health care providers to invest in the machines, which physicians say cost $75,000 to $90,000. But Rad Gharavi, a suburban Oak Park, Ill., psychiatrist who has offered the service for four years, said insurance problems remain.

Coverage begins only after a patient has failed to get better after trying antidepressants. Gharavi said that can force patients to endure the side effects of medications for months.

"That means we are essentially delaying treatment," he said. "TMS can literally take away all the symptoms in six weeks."

It was more complicated than that for the Linden Oaks patient, who has dealt with depression since she was a teenager. She first received the treatment four years ago but comes for follow-up treatments every three months or so when she "can feel the beast creeping up," she said.

"It's apparently very individualized," she said. "There's been a bit of fine-tuning in terms of knowing when to come back for a booster."

Philip Janicak, a psychiatrist who has researched and performed TMS and is now helping Linden Oaks set up its program, said a recent study to which he contributed found that, generally speaking, the effects of the treatment last for a year.

With TMS now firmly established as a depression treatment, Janicak said research is turning to other possible uses, from migraines to Parkinson's disease to post-traumatic stress disorder.

"I see us really at the opening of this era," he said. "There's a lot of things we can do with this technology to help people, and we're just starting to touch the surface of it with depression."

For information on repetitive TMS at Froedtert and the Medical College of Wisconsin, call (414) 955-8952.

Jan Uebelherr of the Journal Sentinel staff contributed to this report.

Saturday, October 18, 2014

Grant Enables Researchers to Continue Studying Stroke Recovery

Oct. 20, 2014

Dr. Michael Kilgard

Dr. Robert Rennaker

At UT Dallas, researchers are developing new techniques to aid recovery from stroke. Their efforts recently received a boost thanks to a multimillion-dollar grant from the National Institutes of Health.

Drs. Michael Kilgard and Robert Rennaker will receive $2.3 million over the next five years to test the effectiveness of using vagus nerve stimulation (VNS) to enhance recovery from stroke in an older population.

According to the Centers for Disease Control and Prevention, more than 795,000 people in the United States will experience a stroke every year. Survivors are often left with weakness or paralysis of their limbs.

“Things like feeding yourself, brushing your teeth, putting your clothes on by yourself — all of those things are almost impossible if you’ve lost upper limb function on one side,” said Rennaker, head of the bioengineering department and director of the Texas Biomedical Device Center at UT Dallas.

Stroke is the No. 1 cause of disability in the United States, but it is also one of the easiest neurological disorders to study because it has a clearly defined cause, according to Kilgard, the Margaret Fonde Jonsson Professor in the School of Behavioral and Brain Sciences. Other brain disorders are more difficult to study because they result from multiple breaks in the nervous system, or their origins are not fully understood, he said.

Strokes occur when blood flow to the brain is interrupted, due to either a blockage (ischemic stroke) or a ruptured blood vessel (hemorrhagic stroke). Blood normally delivers life-sustaining oxygen to the brain. But without that timely and constant delivery, the affected areas become damaged and can eventually result in disability or death to the individual.

Some recovery can occur naturally after a stroke and restore some of the lost brain function. The ability of the brain to change after a stroke is referred to as neuroplasticity. Kilgard and Rennaker are using VNS to try to enhance that neuroplasticity and increase the recovered motor function.

VNS is an FDA-approved method for treating various illnesses, such as depression and epilepsy. It involves sending a mild electric pulse through the vagus nerve, which is in the neck and relays information about the state of the body to the brain.

“We’re interested in learning what is changing in the brain as a result of the VNS therapy, and how those changes lead to recovery.”

Dr. Michael Kilgard,the Margaret Fonde Jonsson Professor in the School of Behavioral and Brain Sciences

Recent research at UT Dallas explored the use of VNS to enhance recovery from the two types of stroke. Last year, Dr. Navid Khodaparast published research describing the complete recovery of animals’ upper limb function after an ischemic stroke. In August, Dr. Seth Hays demonstrated an improvement in recovery from a hemorrhagic stroke in rats.

The new research project will employ an animal model to examine how effective VNS therapy is in an older population. According to the American Heart Association, the risk of having a stroke approximately doubles for every decade of life over 55 years.

“We’re interested in learning what is changing in the brain as a result of the VNS therapy, and how those changes lead to recovery,” Kilgard said.

Specifically, the researchers will examine changes in dendrites, the part of nerve cells in the brain that receives signals from other neurons. They’ll focus on the motor cortex region of the brain controlling upper limb function. They predict VNS therapy might increase dendritic growth in areas of the brain involved in recovery.

Researchers also will examine the connections between the neurons across the two sides of the brain. In a healthy animal, the right side of the brain controls the left side of the body and vice versa for the other side. In an animal recovering from brain damage to one side, recovery could be due to the surrounding undamaged areas taking over the work of the damaged areas or the other side of the brain taking over. Tracing the connections will allow the researchers to see which area of the brain is taking control, providing insight into where the recovery is taking place.

“Although we focus a lot on figuring out the basic science behind why VNS therapy works, our overall goal is to eventually improve the lives of patients,” Kilgard said. “Research like this will help us do that.”

About Me

I'm a very, very long-time support person and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.